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Clinical Trials/NCT02468609
NCT02468609UnknownNot Applicable

Diagnostic Value of Ultralow-dose Computed Tomography for the Detection of Pulmonary Nodules and Lung Parenchym Alterations Compared to Standard-dose CT

Cantonal Hospital of St. Gallen2 sites in 1 country500 target enrollmentStarted: January 2015Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Enrollment
500
Locations
2
Primary Endpoint
Number of pulmonary Nodules detected in the Ultralow-Dose thoracic CT
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

To investigate the diagnostic value of ultralow-dose computed tomography in the detection of pulmonary nodules and lung parenchym alterations (e.g. emphysema) compared to standard-dose-CT.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Diagnostic
Masking
Single (Investigator)

Eligibility Criteria

Ages
18 Years to 90 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •planned normal dose-CT by clinical indication at our institution
  • •obtained informed consent

Exclusion Criteria

  • •planned lowdose-CT by clinical indication at institution
  • •no informed consent obtained
  • •age < 18 years
  • •pregnancy

Outcomes

Primary Outcomes

Number of pulmonary Nodules detected in the Ultralow-Dose thoracic CT

Time Frame: Participants CT-scan will be read out on an average date of 6 weeks after the scan

Difference in nodule detectability in Ultralow-Dose-CT compared to Standard-Dose-CT measured using McNemar test

Secondary Outcomes

  • Patients BMI (Body mass index)(Measures assessed at time of read-out on an average date of 6 weeks after the scan)
  • Patients Nodule size (mm)(Measures assessed at time of read-out on an average date of 6 weeks after the scan)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Michael Messerli

MD

Cantonal Hospital of St. Gallen

Study Sites (2)

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